Hundreds of Medical Devices & Accessories - 3 DHF's?

A

Anoniem

#1
Goodmorning!

Thank you for all the help this forum gave me. I need some direction, hopefully somebody can help me with this:

We develop and manufacture medical devices; class 1 (EU) class2 (USA). Since we start to export to the USA, I would like to reorganize the DHF's.

We have about 500 sellingcodes, all different configurations of- or accessories to the parent medical devices. These can be divided into 3 groups with each their own intended use. So I was planning to create 3 main DHF's which include the most complex and risk full devices, the parent devices. (about 30) I can include the requirements, risk analysis, verification, validation etc for those devices.

But how can I prove a FDA auditor that we planned and controlled the design of the other configurations and accessories? An excel list with references?

Thank you for your support!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Hundreds of devices & accessories, 3 DHF's?

Generally speaking, I don't see a problem with dividing your product range into 3 families and creating 1 DHF for each. However, if your design control documentation is not complete (some devices design / development is not covered by the existing docs) it might be a problem. Most US class II devices need design control, regardless of whether you consider them low-risk or not complex.
 
Q

QA-Man

#3
Re: Hundreds of devices & accessories, 3 DHF's?

If you're reorganizing your documents (or doing anything that's not routine) make a Quality Plan that describes the purpose, scope, responsibilities, milestones, etc. Hold some meetings to review things and update your plan.

This way if you're questioned on the reorganization you can demonstrate that you ensured the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented - (bold an italic text copied from ISO 13485 2003 definition of QMS Planning)
 

rwend07

Involved In Discussions
#4
Re: Hundreds of devices & accessories, 3 DHF's?

Generally speaking, I don't see a problem with dividing your product range into 3 families and creating 1 DHF for each. However, if your design control documentation is not complete (some devices design / development is not covered by the existing docs) it might be a problem. Most US class II devices need design control, regardless of whether you consider them low-risk or not complex.
Going along with this, although accessories generally fall into the same category as the parent device, if the accessories are clearly a different device that could fall into class I, it may be worth leaving them out of the main DHF's and have them listed under a Class I classification as they would not then need design controls. This would only work if they clearly fit into a listing other than the parent device that is in Class I.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Hundreds of devices & accessories, 3 DHF's?

Going along with this, although accessories generally fall into the same category as the parent device, if the accessories are clearly a different device that could fall into class I, it may be worth leaving them out of the main DHF's and have them listed under a Class I classification as they would not then need design controls. This would only work if they clearly fit into a listing other than the parent device that is in Class I.
Not all class I devices are exempt from Design Control, so it needs to be verified for each case.
 

rwend07

Involved In Discussions
#6
Re: Hundreds of devices & accessories, 3 DHF's?

Not all class I devices are exempt from Design Control, so it needs to be verified for each case.
Correct, sorry for the confusion. I would say that if a part is a minor accessory to a parent device it is unlikely to fall into one of the categories of Class I that requires design control though. Either way, it's worth considering.
 
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